Clinical trial · Interventional
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma
NCT04039607CI-TRIAL-00123645CheckMate 9DWcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| lenvatinib | Drug | Lenvatinib | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab + Ipilimumab
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib/lenvatinib
- interventionNames
- Drug: Sorafenib
- Drug: lenvatinib
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 4 years
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have a diagnosis of HCC based on histological confirmation * Participants must have an advanced HCC * Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion * Child-Pugh score 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1 Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Prior liver transplant * Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization * Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Bruno Sangro, Peter Galle, David Tai et al. · Future Oncol · Sep 22, 2026 · PMID 42770869 pubmed
- DERIVEDYau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Matilla Pena A, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M. A plain language summary of the CheckMate 9DW study: nivolumab in combination with ipilimumab for unresectable hepatocellular carcinoma (advanced liver cancer). Future Oncol. 2026 Apr;22(10):1135-1152. doi: 10.1080/14796694.2026.2651375. Epub 2026 Apr 14. PMID 41981891
- DERIVEDYau T, Galle PR, Decaens T, Sangro B, Qin S, da Fonseca LG, Karachiwala H, Blanc JF, Park JW, Gane E, Pinter M, Pena AM, Ikeda M, Tai D, Santoro A, Pizarro G, Chiu CF, Schenker M, He A, Chon HJ, Wojcik-Tomaszewska J, Verset G, Wang QQ, Stromko C, Neely J, Singh P, Jimenez Exposito MJ, Kudo M; CheckMate 9DW investigators. Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial. Lancet. 2025 May 24;405(10492):1851-1864. doi: 10.1016/S0140-6736(25)00403-9. Epub 2025 May 8.